Asset / Drug

FDA

Drug and asset intelligence for FDA with 27 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 27
Catalysts: 0
Stage: Development stage unavailable

Sponsor company

THEA PHARMA →

Mechanism of action

JAK Inhibitor

Recent signals(27)

RegulatoryJune 21, 2026

FDA Grants AP Status for Clindamycin Phosphate ANDA064050 by Padagis US

The FDA has granted abbreviated approval (AP) status for the ANDA064050 application for Clindamycin Phosphate submitted by Padagis US.

StrategyJune 21, 2026

FDA Grants Approval for Propranolol Hydrochloride ANDA219165

The FDA has granted approval for the ANDA219165 application for Propranolol Hydrochloride submitted by PAI Holdings.

RegulatoryJune 21, 2026

FDA Grants AP Status for Fosaprepitant Dimeglumine ANDA212143

The FDA has granted approval status (AP) for the ANDA212143 application for Fosaprepitant Dimeglumine submitted by Chia Tai Tianqing.

RegulatoryJune 21, 2026

FDA Accepts Supplemental Application for Malarone Pediatric

The FDA has accepted a supplemental application for Malarone Pediatric, containing atovaquone and proguanil hydrochloride.

StrategyJune 21, 2026

FDA Grants AP Status for Dorzolamide Hydrochloride ANDA205294

The FDA has granted Abbreviated Approval (AP) status for ANDA205294, a generic formulation of Dorzolamide Hydrochloride.

StrategyJune 21, 2026

FDA Approves ANDA for Valacyclovir Hydrochloride by Hetero Labs

The FDA has approved ANDA203047 for Valacyclovir Hydrochloride submitted by Hetero Labs.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA218821 by Concord Biotech

The FDA has granted approval for ANDA218821, a generic version of tofacitinib citrate submitted by Concord Biotech.

StrategyJune 21, 2026

FDA Grants Approval for Tofacitinib Citrate ANDA218900 by Saptalis Pharmaceuticals

The FDA has granted approval for ANDA218900, a generic version of Tofacitinib Citrate, submitted by Saptalis Pharmaceuticals.

RegulatoryJune 21, 2026

FDA Approves Supplement for Vancomycin Hydrochloride in Plastic Container

The FDA has approved a supplemental application for Vancomycin Hydrochloride in a plastic container by Baxter Healthcare.

RegulatoryJune 21, 2026

FDA Grants AP Status for Losartan Potassium ANDA090382 by Strides Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Losartan Potassium submitted by Strides Pharma.

RegulatoryJune 21, 2026

FDA Approves Supplement for Estradiol by Mylan Technologies

The FDA has approved a supplemental application for estradiol submitted by Mylan Technologies.

RegulatoryJune 21, 2026

FDA Grants Priority Review for Pfizer's Marstacimab (HYMPAVZI) Supplement

The FDA has granted priority review status for the supplemental application of Marstacimab (HYMPAVZI) by Pfizer.

RegulatoryJune 20, 2026

FDA Grants AP Status for Acetazolamide Sodium ANDA202693

The FDA has granted approval status (AP) for the Abbreviated New Drug Application (ANDA) 202693 for Acetazolamide Sodium submitted by Avet Lifesciences.

RegulatoryJune 20, 2026

FDA Accepts ANDA for Dextromethorphan Hydrobromide and Quinidine Sulfate by Sun Pharma

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Dextromethorphan Hydrobromide and Quinidine Sulfate submitted by Sun Pharma.

StrategyJune 20, 2026

FDA Alerts Providers to Supply Disruption of Breast Biopsy Needles

The FDA has notified healthcare providers about a supply disruption affecting Stereotactic Breast Biopsy Needles.

RegulatoryJune 19, 2026

FDA Grants AP Status for Divalproex Sodium ANDA217358 by Mankind Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Divalproex Sodium submitted by Mankind Pharma.

StrategyJune 19, 2026

FDA Approves Hydroxyzine Hydrochloride ANDA220271 by Saptalis Pharmaceuticals

The FDA has approved ANDA220271 for Hydroxyzine Hydrochloride submitted by Saptalis Pharmaceuticals.

RegulatoryJune 19, 2026

FDA Approves First Oral Carbapenem for Complicated UTIs

The FDA has approved the first oral carbapenem therapy specifically for complicated urinary tract infections.

RegulatoryJune 19, 2026

FDA Launches National Priority Voucher Program to Accelerate Drug Review Times

The FDA's new CNPV Pilot Program aims to significantly shorten drug and biologic review times from 10-12 months to 1-2 months.

RegulatoryJune 11, 2026

FDA Clears Bridge Device for Opioid Use Disorder Treatment; Efficacy Under Evaluation

The Bridge Device has received FDA clearance for the treatment of Opioid Use Disorder, emphasizing safety over efficacy.

RegulatoryJune 9, 2026

FDA Grants AP Status for Diltiazem Hydrochloride ANDA216327

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Diltiazem Hydrochloride submitted by Sciegen Pharmaceuticals.

RegulatoryJune 8, 2026

FDA Approval Process Update for Mycophenolate Mofetil by Strides Pharma

The FDA has an active application (ANDA212634) for Mycophenolate Mofetil submitted by Strides Pharma, currently under standard review.

RegulatoryJune 8, 2026

FDA Approves Supplement for Methylprednisolone Acetate by Sandoz

The FDA has approved a supplemental application for Methylprednisolone Acetate submitted by Sandoz.

RegulatoryJune 7, 2026

FDA Approval Status Update for Losartan Potassium by Micro Labs

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Losartan Potassium submitted by Micro Labs.

RegulatoryJune 6, 2026

FDA Accepts Application for COSOPT PF Supplement by THEA PHARMA

The FDA has accepted the supplemental application NDA202667 for COSOPT PF, a glaucoma treatment.

RegulatoryJune 6, 2026

FDA Grants Approval for Phenylephrine Hydrochloride by Baxter Healthcare

The FDA has granted approval for ANDA217032, a new application for Phenylephrine Hydrochloride submitted by Baxter Healthcare.

RegulatoryJune 6, 2026

FDA Submission Update for Ondansetron Hydrochloride (ANDA078127)

The FDA has received a supplemental application (ANDA078127) for Ondansetron Hydrochloride from PHARM ASSOC.

Upcoming milestones

No catalysts indexed for this entity yet.

Related catalysts

No catalysts indexed for this entity yet.

Indications

Infectious Disease →

Opioid Use Disorder →

Therapeutic areas

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